1. Field of the Invention
The present invention relates to breath sampling equipment and in particular to the sampling of air from the lungs of infants.
2. Description of the Background
The constituents of expelled air from a patient's lungs are used for various types of patient diagnoses. To analyze the expelled air, a patient's breath is collected for analysis. A variety of breath collection systems have been developed that generally include a mouthpiece connected to an inlet for inhalation, an outlet for exhalation, and a valve for diverting the exhaled breath into a sampling assembly. These breath collection systems generally use a sampling canister or collection bag to store or transport the breath samples.
For example, U.S. Pat. No. 5,140,993 to Opekun, Jr. et al. issued Aug. 25, 1992, shows a breath collection device that includes a flexible plastic bag having a mouthpiece and inlet valve assembly connected adjacent one end of the bag, and a sample transfer assembly connected adjacent the other end of the bag. A hollow needle penetrates a stopper to permit transfer of a breath sample from the bag to a storage device.
United States Patent Application 20060058696 by Hamilton published Mar. 16, 2006, shows an air sampling apparatus including a bag for containing air and a sensing mechanism coupled to said bag. The self contained sampling and sensing mechanism can be used for visual or other detection of targeted analytes within the breath sample.
United States Patent Application 20030050567 by Baghdassarian published Mar. 13, 2003, shows a device for collecting alveolar breath. A patient exhales a breath into the inlet of a hollow body. The hollow body has two outlets, with a valve disposed in each outlet. The concentration of a specific gaseous component of expired breath is monitored by a gas concentration monitor as the expired breath passes through the hollow body to determine when alveolar breath is present in the hollow body. When alveolar breath is present in the hollow body, the valve in the second outlet is actuated to an open position to collect the alveolar breath in the collection reservoir affixed to the hollow body at the second outlet.
U.S. Pat. No. 5,081,871 to Glaser issued Jan. 21, 1992, shows an apparatus for sampling volumetric quantities of human exhaled breath with three conduits in a “Y” or “T” shaped configuration. The free end of one of the conduits is adapted to connect with the mouth of the subject being tested. Another of the conduits is adapted to pass ambient air to the subject, this conduit being provided with a suitable filtering mechanism, and the third of the three conduits supports an appropriate sampling canister for receiving exhaled breath from the subject. The third conduit is also provided with a one-way check valve.
U.S. Pat. No. 4,190,045 to Bartels issued Feb. 26, 1980, shows a noise reducing exhalation valve and diaphragm for use in exhalation valves of respiratory apparatus to prevent the propagation of harmonic acoustic vibrations. The valve diaphragm employs a cone-shaped central portion.
U.S. Pat. No. 6,723,056 to Alving et al. issued Apr. 20, 2004, shows a device for the collection, storage, or transport of gas samples using a bag with a reagent chamber.
U.S. Pat. No. 6,283,122 to Adahan issued Sep. 4, 2001, shows an exhalation valve for a respirator that includes a hollow flow-through body, an air inlet port, and an air outlet port. The inlet port is connected to a source of compressed air or a respirator, and the air outlet port provides air to a patient. The device also includes an exhalation valve.
United States Patent Application 20040038412 by Yatscoff published Feb. 26, 2004, shows a breath test and kit for the diagnosis of diabetic indications and monitoring glycemic control.
U.S. Pat. No. 5,327,901 to Delente issued Jul. 12, 1994, shows an apparatus for collecting and storing human breath samples including an elongated, hollow container and a breath delivery device for directing a subject's breathe into the container. Self sealing tape is disclosed as a closure means that accommodates the insertion of the breath delivery device into the container and that substantially seals the container.
U.S. Pat. No. 5,467,776 to Hamilton issued Nov. 21, 1995, shows an air sampling device comprising a blow tube connected to a waste air collection bag and an air capture assembly. A person blows a predetermined volume into the blow tube, and after a portion of the air fills the waste bag, a needle pierces a stopper to capture air in a test tube.
In all of the foregoing examples, healthy adults and older children have no problem filling the collection bag, canister, or vial. Infants and other individuals with shallow or weak breathing, however, have difficulties inflating a collection bag, making it difficult for physicians to collect an adequate sample. Very little attention has been directed to this problem.
One example is U.S. Pat. No. 5,924,995 to Klein et al. issued Jul. 20, 1999, which explains how a sample of end-tidal air is collected from a child or infant, and notes that the preferred collection method includes the breath collection device described in U.S. Pat. No. 5,140,993 (above), which includes a resuscitation mask with a one-way inlet valve. The infant's exhaled breath is collected in the collection bag and transferred to an evacuated storage tube, preferably 5 ml in volume. “Older children are capable of blowing directly into the collection bag; or alternatively, they can blow through a straw extending to the bottom of the storage tube when the stopper has been removed. The stopper is replaced after breath collection.” Unfortunately, the referenced valve is not designed for an infant, and capturing an adequate sample remains a problem. Moreover, transferring the infant's exhaled breath from the collection bag to an evacuated storage tube is cumbersome, and this process leaves the sample susceptible to contamination.
It would be greatly advantageous to provide an infant breath collector specifically designed for shallow-infant breathing that is both easy for an infant to expel an adequate sample and easy for a physician to collect an adequate sample.